BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PK PAPYRUS US 3.0/15

    MDR report key: 12656354 · Received October 19, 2021

    Report

    Report Number
    1028232-2021-05779
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 20, 2021
    Report Date
    October 1, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIV
    UDI-DI
    07640130447165
    PMA / PMN Number
    H170004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SECOND PKP WAS PLACED IN AN OVERLAPPING MANNER. THE PERFORATION APPEARED TO BE SEALED, BUT THE PATIENT REQUIRED SURGICAL INTERVENTION. THE INFORMATION PROVIDED SUGGESTED THAT THE TREATED PERFORATION WAS NOT A DEVICE OR PROCEDURE-RELATED COMPLICATION. THE PATIENT PASSED AWAY ONE DAY AFTER THE TREATMENT FOLLOWING TWO EMERGENCY SURGERIES.

    Additional Manufacturer Narrative · 0

    THE SECOND PKP WAS PLACED IN AN OVERLAPPING MANNER. THE PERFORATION APPEARED TO BE SEALED, BUT THE PATIENT REQUIRED SURGICAL INTERVENTION. THE INFORMATION PROVIDED SUGGESTED THAT THE TREATED PERFORATION WAS NOT A DEVICE OR PROCEDURE-RELATED COMPLICATION. THE PATIENT PASSED AWAY ONE DAY AFTER THE TREATMENT FOLLOWING TWO EMERGENCY SURGERIES. THE AFFECTED PK PAPYRUS STENT SYSTEM WAS NOT RETURNED TO BIOTRONIK AND COULD THEREFORE NOT BE SUBJECTED TO A TECHNICAL INVESTIGATION. SIX MANUALLY RECORDED IMAGES OF THE ANGIOGRAPHY RECORDINGS WITH SUBOPTIMAL IMAGE QUALITY WERE PROVIDED. THE INDIVIDUAL IMAGES SHOW THE FOLLOWING SEQUENCES: PKP DEPLOYMENT, VESSEL APPEARS SEALED, PERFORATION PERSISTS, DEPLOYMENT OF SECOND PKP, FINAL IMAGE NO POST DILATATION OF PKP APPEARS SEALED AND POST DILATATION OF PKP. REVIEW OF THE PRODUCT RELEASE DOCUMENTATION CONFIRMED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS DURING WHICH A 100 PERCENT CONTROL OF THE STENT COVER IS PERFORMED. BASED ON THE PROVIDED DOCUMENTATION AND THE CONDUCTED REVIEW NO DEVICE DEFICIENCY OR MANUFACTURING RELATED ROOT CAUSE FOR THE REPORTED POTENTIALLY INSUFFICIENT SEALING OF THE PERFORATION COULD BE IDENTIFIED. THE INFOR-MATION PROVIDED IN THE PK PAPYRUS DEVICE REGISTRATION FORM STATED THAT THERE WAS NO DEVICE OR PROCEDURE-RELATED COMPLICATION. PK PAPYRUS IS INDICATED FOR THE TREATMENT OF ACUTE PERFORATIONS OF NATIVE CORONARY ARTERIES AND CORONARY BYPASS GRAFTS IN VESSELS 2.5 TO 5.0 MM IN DIAMETER. AS SUCH, THIS DEVICE IS TYPICALLY USED IN EMERGENT RESPONSE TO A LIFE-THREATENING ADVERSE PROCEDURAL EVENT UNRELATED TO USE OF THE PK PAPYRUS.

    Description of Event or Problem · 1

    AFTER PRE-DILATATION OF A DISTAL STENOTIC RIGHT CORONARY VEIN GRAFT LESION AND BARE METAL STENT DEPLOYMENT, ANGIOGRAPHIC VISUALIZATION REVEALED A TYPE II PERFORATION IN DISTAL RCA. THE PK PAPYRUS COVERED STENT WAS DEPLOYED FOLLOWED BY ANOTHER POST-DILATATION AND SUCCESSFUL DEPLOYMENT OF ANOTHER BARE METAL STENT. HOWEVER, POST ANGIOGRAPHIC VISUALIZATION REVEALED PERICARDIAL BLUSH IN SAME AREA WHERE THE PK PAPYRUS WAS DEPLOYED. SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556117 PK PAPYRUS US 3.0/15 COVERED CORONARY STENT NIV BIOTRONIK AG, BUELACH, SWITZERLAND 434888 10194682 07640130447165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization